SOURCES SOUGHT
A -- Drug Testing Facility
- Notice Date
- 4/24/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-07-08
- Response Due
- 5/31/2007
- Archive Date
- 6/15/2007
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT, THIS ACQUISISTION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZONE, VOSB, AND SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. THE INTENDED NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES OR LESS. The National Institute of Child Health and Human Development (NICHD) is seeking sources for an intended re-competition of its contract for a Drug Testing Facility (DTF). This project is currently being performed by BIOQUAL, Inc. of Rockville, MD. Background and Acquisition History The Drug Testing Facility of the Contraception and Reproductive Health Branch (CRHB) has been a mainstay of much of the CRHB's operations for over thirty years. The Drug Testing Facility currently screens hundreds of submissions annually for classical endocrine and anti-fertility activity and establishes potency ratios (in terms of standards) for those that exhibit significant effects. They have developed methods for determining the duration of hormonal activity following oral, subcutaneous and topical (transdermal) administration, which has been of enormous value in the assessments thereof. Over 40000 compounds, formulations and drug delivery systems from government, private, international organizations and contractors world-wide have been evaluated since the project was initiated in the early 1970's. The Drug Testing Facility undertakes a variety of over 150 screens, assays, safety tests and analytical laboratory procedures. Theses efforts provide the CRHB with unparalleled capabilities for the evaluation of new drugs, formulations and delivery systems. The results of these various tests are used to guide new synthesis efforts, modifications of formulations and dosage forms. They are also used for the evaluation of optimal bioavailability or studies on the duration of activity, which may be used to provide support of clinical investigations through various safety studies. This subject acquisition will require the successful offeror to provide this level of expertise in all of the areas developed to date and possibly new areas yet unrecognized. Offerors will be encouraged to provide an alternative proposal that incorporates novel methods of testing. Description of the Services The Drug Testing Facility (DTF) assays hundreds of submissions annually for classical endocrine and anti-fertility activity and establishes potency ratios (in terms of standards) for those that exhibit significant effects. The facility also develops methods for determining the duration of biological activity following oral, subcutaneous and topical (transdermal, transvaginal, etc) administration. It evaluates the potential clinical utility of new compositions of matter and formulations thereof. Under NICHD contract, the DTF evaluated submissions that originated from private, university, governmental and non-profit organizations throughout the world. Many submissions also were derived from other NICHD contracts or collaborative programs. A Compound Submission Form is completed by the originator for each compound when the material is provided to the Project Officer. Compound identification, physiochemical properties, purity and analytical data are requested with each submission, whenever available. The decision of whether or not to include the material for testing in the DTF is made by the Project Officer in consultation with other staff of the Contraception and Reproductive Health Branch (CRHB) of the National Institute of Child Health and Human Development (NICHD). The Project Officer provides the Contractor with the test sample and a copy of the Compound Submission Form. Frequent contact between the Project Officer and the Contractor allows advanced notice of compounds expected for testing. The DTF must be capable of performing a wide range of screens, assays, safety tests and analytical procedures for the evaluation of new compounds, formulations and delivery systems. The results of theses tests may be used to support patent applications by submitters, as well as the CRHB, NICHD. As new technologies become available, the facility must be capable of incorporating new and innovative assays/tests into their portfolio (either in house or through subcontracts) to meet the needs of CRHB. The DTF must be capable of performing and providing at least the following competencies: 1. Toxicology studies, including acute, subacute, subchronic, chronic, reproductive and genetic, may be undertaken in-house or through subcontracts. 2. Rabbit vaginal irritation testing for the evaluation of formulations of spermicides and microbicides to include both gross and histopathological examination of external genitalia and cervix. Services of a board certified pathologist are required for performance of both gross and microscopic examinations. This test is usually performed under "Good Laboratory Practices" (GLP) Guidelines so that, if necessary, the results may be submitted to the FDA in support of a Notice of Claimed Investigational Exemption for a New Drug (IND) initiation of clinical investigations. New compounds and/ or formulations must have an IND before clinical work can proceed. 3. Contraceptive efficacy tests are required to predict clinical activity of potential contraceptives. Dose-response and time related efficacy curves must be provided for comparison with various standards. 4. Growth and maintenance of cell cultures for the conduct of in vitro assays required for evaluation of compounds. Theses assays include, but are not limited to, transfection of specific cell lines with estrogen and progesterone receptor expression plasmids and appropriate reporter constructs. These in vitro tests will permit a more thorough exploration of tissue-specific effects of a number of steroids, their antagonists, and other compounds exhibiting antifertility activities. All responsible sources may submit a capability statement for consideration. Address how your company is able to meet the above four competencies. Please email your capability statements of 10 pages or less in a Word document to Katharine Minker at minkerk@niddk.nih.gov. No additional information regarding the upcoming RFP is available at this time. Please do not telephone or email the Contract Specialist seeking additional information. A pre-solicitation notice will be posted that will advise when the RFP will be released. Your response, composed of a brief cover letter and completed Capability Profile, should be submitted via E-mail, FAX, or mail, within 21 days of the date of this publication, to: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Attention: Ms. Katharine Minker, Contract Specialist Contracts Management Branch, Office of Acquisitions, NICHD 6100 Executive Boulevard, Suite 7A07, MSC 7510 NOTE: For U.S. Mail: Bethesda, MD 20892-7510 NOTE: FedEx/Hand Delivery: Rockville, MD 20852 Email: Minkerk@niddk.nih.gov FAX: 301-402-3676
- Record
- SN01279927-W 20070426/070424220351 (fbodaily.com)
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